Pediatric Endocrinologists' Statement on Growth Hormone Safety Alert
FDA Alert
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MADISON - Recently, the U.S. Food and Drug Administration (FDA) issued an alert concerning the safety of growth hormones.
The alert was prompted by a study in France that suggested a small increased rate of death among patients treated with growth hormone between 1985 and 1995, compared to individuals in the general population of France.
In response to the alert, the Pediatric Endocrine Society, a national society of endocrinologists who treat children, released a statement. UW Health's pediatric endocrinologists, all of whom are members of the society, endorse the news release. The information follows:
"The Pediatric Endocrine Society, the professional medical organization representing 1,200 pediatric endocrinologists in North America, has released its comments on a recent FDA drug safety alert regarding the administration of recombinant human growth hormone.
"This alert arose from a study conducted in France which found that individuals treated with recombinant human growth hormone during childhood and followed over a long period of time had a small increased risk of death when compared to individuals in the general population of France.
"The French investigators are conducting additional statistical studies and reviews of their data to determine if the preliminary conclusions are valid.
"The FDA recommends that patients not discontinue recombinant human growth hormone without talking to their healthcare professionals. The FDA concludes with a statement that the benefits of growth hormone administration continue to outweigh its potential risks.
"The Pediatric Endocrine Society recommends that physicians review the FDA drug safety alert and await definitive information from both the French investigators and the FDA.
"Parents and patients should consult with their physicians if they have questions."
News tag(s): pediatric endocrinology, children